MAUDE Adverse Event Report: COLOPLAST A/S SAFFRON FIXATION TOOL; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE

Catalog Number 520340

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

According to the available information the surgeon deployed the device and noted that it was difficult to remove after placing the anchor.After examining the device, it was concluded that the anchor deployer was bent and unable to withdraw back into handset.She opened another device and completed case.It was noted there was no injury to patient.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified at the time of search.

Manufacturer Narrative

A saffron delivery tool was received for evaluation.A crack in the distal tip was noted with the saffron device.Examination of the distal tip revealed a bent cannula associated with incorrect anchor placement into rigid structure (i.E.Bone) or debris logged into distal tip assembly.A saffron delivery device was returned for evaluation.No anchors were received.A crack in the distal tip was noted originating near the anchor retainers downward the end of distal tip housing.As the information received indicated that the surgeon had difficulty removing the device after placing the anchor, it was concluded that incorrect anchor placement into rigid structure may have led to the stuck plunger and bent cannula.The lot number was reviewed for complaint trend, nonconforming report, and capa.An investigation into this lot was executed including analysis of another complaint's return with this same lot # and reported issue.As a result of the investigation, (b)(4) has been opened to investigate root cause of a nonconformity, correction, and any further containment actions based upon determined scope.

Event Description

According to the available information the surgeon deployed the device and noted that it was difficult to remove after placing the anchor.After examining the device, it was concluded that the anchor deployer was bent and unable to withdraw back into handset.She opened another device and completed case.It was noted there was no injury to patient.

• Brand Name: SAFFRON FIXATION TOOL
• Type of Device: SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18888095
• MDR Text Key: 337469033
• Report Number: 2125050-2024-00400
• Device Sequence Number: 1
• Product Code: PBQ
• UDI-Device Identifier: 05708932757423
• UDI-Public: 05708932757423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520340
• Device Lot Number: 8921908_5203401400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR